Novartis tells SC it has right to patent its cancer drug

New Delhi: The Supreme Court today asked Swiss pharma giant Novartis AG whether it should not sell its anti-cancer drug for Rs 5 each to benefit common man.

A bench of Justices Aftab Alam and Ranajan Prakash Desai posed the query to Novartis AG while hearing its plea seeking affirmation of the exclusivity of its blood cancer drug Glivec and its right to get it patented in India.

"Why don`t you sell it for Rs 5? People find it difficult to buy it," the bench asked senior counsel Goapl Subramanium as he, appearing for the firm, argued that getting the drug patented would not affect the treatment of the poor.

Taking a dig at the huge cost of the drug, the bench remarked in a lighter vein the cost was perhaps prohibitive even for the apex court judges.

"The monthly cost of Rs 1.2 lakh is too high. The government may revoke our reimbursement of medical bill if it goes to that extent," the bench quipped.

The bench observed that public "trust comes not from the pricing but from the efficacy of the drug."

It made the observation as Subramanium asserted that it has the right to patent its blood cancer drug as it was a completely new medicine, while seeking to assure the court that treatment to the poor patients would not be affected because of it.

The firm tried to dispel the impression that its drug would be beyond the reach of the poor cancer patients as the bench said the pricing of the medicine was in its sub-conscious mind as the monthly dosage costs around Rs 1.2 lakh.

"The purpose is not to make money from the poor. This is not the purpose but am I not entitled for patent for our drug? We are fighting the case on principle," said Subramanium.

"We are totally conscious of our social responsibility. Conduct of Novartis is socially responsible and we are fighting for our rights for patent," he said when the bench observed that the cost of the drug is too high.

Subramanium, however, submitted that there should be no cause of concern that the poor would not get treatment and submitted that 85 percent of the patients are treated free under its scheme.

As the apex court commenced its final hearing over the Novartis AG`s plea for getting its blood cancer drug Glivec patented in India, the firm submitted it has done lot of research and spent around 800 million dollar to bring it out.

The firm also refuted allegations of various social organisations that it was just an attempt by Novartis to evergreen its patent right.

Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew it by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.
Under it, either they take a new patent or stretch the time permissible under the law.

Earlier, the Indian patent authorities had denied the exclusivity claims of Novartis and later it was also upheld by the appellate board IPAB. Novartis has challenged the order of Chennai-based Intellectual Property Appellate Board (IPAB), which rejected its appeal against patent department`s decision on Glivec.

The Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law.

Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy.

Section 3(b) restricts patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.

In 2003, Novartis had obtained exclusive marketing rights (generic versions of Glivec were stopped from being made) for the drug, based on its patent application.

While the Swiss firm had challenged the patent office`s verdict in the Madras High Court, its appeals were transferred to IPAB, which held in July 2009 that Glivec did not meet the requirement of increased therapeutic efficacy.